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    CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

    FDA Recall
    Terminated ·Accuray Incorporated·Product code IYE·September 12, 2011

    syngo RT Therapist and syngo RT Therapist Connect/MOSAIQ OIS. This correction applies to customers who use the syngo RT Therapist v4.2 or the combination of syngo RT Therapist v4.2 with syngo RT Oncologist v4.2 from Siemens. 12/7/2011: Update: Syngo RTT4.2.108 SW contains the same SW content when installed on the syngo Oncologist Workspace (license key controlled). Currently the syngo Oncologist SW version is 4.2.92 P04. By installing this update, the Oncologist will match the RTT version 4.2.108. The intended use of the Siemens branded Artiste, Oncor and Primus family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·November 2, 2011

    ARTISTE and ONCOR linear accelerators with G31 mother board. ARTISTE and ONCOR are manufactured by Siemens Medical Solutions, Roentgenstrasse 19-21, Kemnath, Germany. ARTISTE, ONCOR and PRIMUS family of linear accelerators deliver X-ray photon and electron radiation for therapeutic treatment of cancer.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·November 9, 2011

    Precise Digital Accelerator Delivery of radiation to defined target volumes

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·August 6, 2012

    Synergy XVI Intended for radiation therapy treatment.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·April 23, 2014

    Mevatron KDS-2 Medical Linear Accelerator, Material Number: 9822693, with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    MEVATRON M-2 6300 Medical Linear Accelerator, Material Number: 09401316 with control console software versions 6.5/7.2, 8.0, 9.0 and 9.1, Manufactured by Siemens Medical Solutions USA, Inc, Concord, CA

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·January 11, 2008

    SEQUENCER for Mosaiq interfaced to Electa SL75-5 machines. Sequencer Verify and Record System is to assist in the process of patient treatment on a radiotherapy treatment machine with software control.

    FDA Recall
    Terminated ·Impac Medical Systems Inc·Product code IYE·March 10, 2010

    C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA. Device is a radiation Therapy accelerator intended to deliver megavoltage x-ray treatments for conventional radiotherapy (three dimensional conformal radiotherapy and intensity modulated radiotherapy) and stereotactic radiosurgery and radiotherapy. Stereotactic treatments are inteded for therapy of lesions such as arteriovenous malformations, primary tumors and metastatses. Stereotactic treatments may be intracranial or extracranial and consist of single-session or fractionated delivery.

    FDA Recall
    Terminated ·Varian Medical Systems Oncology Systems·Product code IYE·October 8, 2009

    CyberKnife System Robotic Radiosurgery System, (Robocouch Patient positioning System) Synchrony Respiratory Tracking System, a Radiation therapy device, Model Numbers: 026430, 028186, Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA A Radiation therapy device.

    FDA Recall
    Terminated ·Accuray Inc·Product code IYE·March 16, 2009

    Elekta Synergy XVI Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner.

    FDA Recall
    Terminated ·Elekta, Inc.·Product code IYE·January 5, 2011

    MEVATRON M-2 6700,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401407,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

    MEVATRON M-2 6740,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 9401506,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

    ONCOR Avant Garde,Medical charge-particle radiation therapy system (Medical Digital Linear Accelerator),MODEL NUMBER: 5863472,MANUFACTURED BY: Siemens Medical Solutions USA, Inc, 4040 Nelson Ave, Concord, CA 94520

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·March 22, 2007

    Varian Medical Systems Clinac Medical Linear Accelerator. Clinac 600 C &C/D, Clinac 2100 C, C/D & EX and Clinac 2300 C &C/D

    FDA Recall
    Terminated ·Varian Medical Systems Inc·Product code IYE·May 2, 2007

    Fiducial Markers (0.9 x 3 mm) Soft tissue gold markers, Medical charged-particle radiation therapy system; Part Number: MT-NW-887-809, CIVCO Medical Solutions (MEDTEC), Orange City, IA 51041.

    FDA Recall
    Terminated ·Med Tec Inc dba CIVCO Medical Solutions·Product code IYE·February 28, 2008

    Artiste MV system, Part number 8139789, medical linear accelerator equipped with COHERENCE therapist RTT4.1. Medical Linear accelerator for radiation therapy. The device utilizes a console system for selecting various treatment sequences and manages commands for all motorized movement.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·July 4, 2008

    Coherence Therapist 2.0 equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 8139839 Medical charged-particle radiation therapy system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·November 6, 2007

    Coherence Impression Therapist System equipped with a Coherence Therapist R2.0 or R2.1, and PRIMEVIEW 3iR2.0 or R2.1, part number 7341410 Medical charged-particle radiation therapy system.

    FDA Recall
    Terminated ·Siemens Medical Solutions USA, Inc·Product code IYE·November 6, 2007

    CIVCO MTAPSID2932 Type-S Thermoplastic, Disposable nonsterile (48.3 cm) IMRT Style 29 thermoplastic (3.2 mm), Ref. MTAPSID2932, disposable frame mask, 5 per box. The firm name on the label is CIVCO, Orange City, IA. Intended to be used for patient fixation.

    FDA Recall
    Terminated ·Med Tec Inc·Product code IYE·August 31, 2009